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The Latest Breaking News from EMA

Understaffing and wellbeing weigh on business

Employees report poor health outcomes due to pressures in the workplace, with deleterious effects on the future of small businesses as well as the national happiness quotient.

Newsroom.co.nz

Recap Of Monday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has announced clearance to Insulet’s (NASDAQ:PODD) Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D). Insulet shares traded in a range of $260.13 to $266.73 on day volume of 200.86 thousand shares…

Benzinga

EU backs changing monkeypox vaccine injection method to boost supply

European countries could stretch out limited supplies of the monkeypox vaccine by administering smaller doses of the shot, the European Medicines Agency (EMA) said on Friday.

Reuters

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EU regulator OKs plan to increase monkeypox vaccine supplies

The European Medicines Agency said a smaller dose of the monkeypox vaccine appears to still be effective and can be used to stretch the current supply by five times, echoing a recommendation made earlier this month by the U.S. Food and Drug Administration

The Independent UK

East Midlands Airport details plans to deal with demand amid surge in passengers

The airport has seen record numbers returning after Covid restrictions

Nottingham Post

The sleepless nights, stress, and financial worries that make it near-impossible for young carers to stay in school

Dylan Thomas, 18, fell asleep in class and some teachers "didn't care" when he was absent

Wales Online

EU says Novavax COVID shot must carry heart side-effect warning

The European Medicines Agency (EMA) is recommending Novavax's COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.

Reuters

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Bavarian Nordic monkeypox vaccine wins EU approval

Danish biotechnology company Bavarian Nordic said on Monday the European Commission had given permission for its Imvanex vaccine to be marketed as protection against monkeypox, as recommended last week by the European Medicines Agency (EMA).

Reuters

How the pandemic set back drug safety

The best form of inspection is an unannounced one, but the pandemic changed the game for regulators. They’ll need to work together to protect consumers.

360info

EU drug regulator recommends clearing vaccine for monkeypox

The European Medicines Agency says the smallpox vaccine made by Bavarian Nordic should also be authorized against monkeypox as an outbreak of the once-rare disease sickens people across Europe

The Independent UK

Pfizer (PFE), BioNTech Seek EU Nod For Omicron-Based COVID Jab

Pfizer (NYSE: PFE) and its partner, BioNTech (NASDAQ: BNTX) announced that they have completed the submission of a regulatory application to the European Medicines Agency (EMA), which seeks authorization for thei

Benzinga

No, boosters aren't bad for you

A conspiracy theory about booster shots resurfaced this month — here’s what experts say

Salon

East Midlands Airport rules for baggage drop off and what you can't take on a plane

It is important to check the details

Nottingham Post

Novavax (NVAX) Down As EU Adds Side Effects To COVID Jab Label

Shares of Novavax (NASDAQ: NVAX) fell 26.2% on Jul 14, after the European Medicines Agency's (TSE: EMA) Pharmacovigilance Risk Assessment Committee ("PRAC") updated the product label of Nuvaxovid, the company's COVID-19 vaccine, to include some potential side effects like severe aller

Benzinga

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Nottingham Post

East Midlands Airport update on summer holiday check in times

They are keen to minimise delays

Benzinga

InflaRx Provides Development Update For Vilobelimab In Skin Disorder, COVID-19

InflaRx N.V. (NASDAQ:IFRX) provided a development update for its monoclonal anti-C5a antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19. The FDA and the European Medicines Agency (EMA) have granted orphan drug designation to vilobelimab for PG. PG is a rare condition that causes large, painful sores (ulcers) to develop on the skin.…

Benzinga

Adverum Biotech Receives EMA's Priority Medicines Status For Chronic Eye Disorder Candidate

The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Adverum Biotechnologies’ (NASDAQ: ADVM) lead drug ADVM-022 for the treatment of wet age-related macular degeneration (wet AMD).

Benzinga

BioNTech Gets EMA's Priority Medicines Status For Testicular Cancer Drug

BioNTech (NASDAQ: BNTX) received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for its product candidate BNT211 in the third- or later-line treatment of testicular germ cell tumors.

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The Independent UK

EU regulator authorizes COVID shot made by France's Valneva

The European Medicines Agency says it is recommending the authorization of the coronavirus vaccine made by French pharmaceutical Valneva, making it the sixth shot to be given the green light in Europe

Motorsport

Nasr to make Spa 24 Hours debut in EMA Porsche

Ex-Formula 1 driver Felipe Nasr will make his Spa 24 Hours debut next month as part of an all-factory driver line-up in a Porsche fielded by Australian entrant EMA Motorsport.

Autosport

Ex-F1 driver Nasr to make Spa 24 Hours debut in EMA Porsche

Ex-Formula 1 driver Felipe Nasr will make his Spa 24 Hours debut next month as part of an all-factory driver line-up in a Porsche fielded by Australian entrant EMA Motorsport.

Benzinga

Legend Biotech Shares Move Higher After Bullish BMO Pitch

BMO Capital Markets initiated coverage on Legend Biotech Corporation (NASDAQ:LEGN) with a price target of $77, and an Outperform rating. The analyst says the company's recently approved Carvykti for multiple myeloma is best-in-class late-line CAR T therapy. Related: EMA's CHMP Clears Janssen, Legend's Multiple Myeloma CAR-T Therapy Though the analyst expects a gradual increase in sales due…

Nottingham Post

East Midlands Airport announces summer changes to deal with huge number of passengers

“We want our passengers to have the best possible start to their trips and holidays"

Nottingham Post

East Midlands Airport joint statement after flights divert over 'drone sightings' at Download

Police patrols have increased

Nottingham Post

Giant fungus spreading into rivers near East Midlands Airport being investigated

Concerns have been raised about the impact of the process

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